1. Field of the Invention
The invention relates to medicine and to therapeutic-prophylactic nutrition, and more particularly, to biologically active additives to food and to compounds that normalize function of the reproductive organs, and to restoring testosterone level in the body that is lowered due to different types of sexual and metabolic disorders, such as hypogonadism.
2. Description of the Related Art
Two conventional methods are widely known to prevent and treat sexual and metabolic disorders:
treatment with hormonal compounds, primarily by testosterone injections, and
treatment with infusions and extracts of plant origin.
Also, a use of vasodilators as a method that permits a certain increase in hormonal background, combined with restoration of erectile function by itself and combined with prehormones of plant origin, has become increasingly popular in recent years.
Sexual function is an important component of the reproductive system of the body, since normal sexual functioning of the body is often psychologically much more important for men than for women. In developed countries, the frequency of sexual disorders among men is steadily increasing, which dictates the need to investigate the mechanisms of normal or altered sexual function (WHO, 2004).
Male reproductive function of the body is subject to influence of different ecological, chemical, physical and biological factors, such as heredity, environment and stress. Many factors lead to a reduction in testosterone production. However, psychological factors also lead to a significant degree to a reduction in testosterone level. Dysregulation of central mechanisms that play a critical role in the development of sexual motivation, on which sexual function depends, is the reason for most disorders in male sexual function.
Synthesis of testosterone is ultimately a complex integrative process consisting of central motivational and peripheral copulatory mechanisms. The mechanisms that regulate sexual function are ensured to a significant degree by neuronal processes of the preoptic zone of the hypothalamus, which are activated by different neuromediator systems—dopamine (DA), acetylcholine (AC), 5-hydroxytryptamine (5-HT), and noradrenaline (NA) (Bitran, 1987; Dorner, 1989; Gladkova, 2000).
Treatment of testosterone deficiency by testosterone injections began about 50 years ago. Originally, an attempt was made to create drug forms of the noninjection type, but two problems were discovered. The first is that testosterone is unstable during storage, and the second is that testosterone is introduced to the body through the nasal mucosa or by being taken internally through the stomach. Treatment of impotence and partially male infertility, even today, is accomplished by testosterone injections, but this method has a number of limitations and problems. First, the tolerability of such injections is low. Only a third of patients tolerate the injections without discomfort, and a quarter of the patients cannot tolerate it because of pain. Second, the effectiveness of such injections is short-lived, at most a few hours. Third, resistance gradually develops, which requires an increase in therapeutic dose. For this reason, the search for a safe and effective means to restore the free testosterone level in males is still very important.
The most widely used method at present for increasing testosterone level is the creation of compositions based on plant extracts that include prehormonal compounds, different phytosteroids and specific alkaloids. Such compositions come from traditional medicine: ancient Chinese, Himalayan and Ayurvedic. Modern agents have been optimized according to composition of the extracts, production technology, dosage and determination of the activity of the active ingredients. Compound based on Testofen (Trigonella foenum-graecum), an extract obtained microbiologically, is the most widespread today. It is based on a broad spectrum of steroids, prehormones and glycosides. These compounds include Vitaly-T-Aid (composition: Testofen 600 mg, Male Wellness blend 100 mg, saw palmetto berry powder, astragalus root powder, phytosterol, Asian ginseng root powder, tribulus fruit extract, L-arginine), T Strong (composition: LJ100® Long Jack, L-arginine, L-citrulline, β sitosterols) and others.
This group includes the compound Tribestan that has recently become common in Europe, whose active ingredients are steroid saponins of the furastanol type, among which protodioscin predominates, obtained from the above-ground part of Tribulus terrestris L. (devil's thorn). This year-around plant is found throughout the world.
Two factors are the main shortcomings of these agents. First, these agents do not eliminate (even partially) the reason for development of testosterone deficiency. Rather, they only partially unload the actual organ mechanisms of hormonal synthesis, and second, they do not ensure a prolonged effect, especially after termination of taking of the compound.
As a rule, testosterone deficiencies are accompanied by a reduction in erectile function, for which reason there are number of studies based on the vasodilatory of a number of compounds, see EP 0463450 (Vasoactive intestinal polypeptide analogues and use thereof), EP 1041880 (Administration of arginine to warm cool/cold tissue), U.S. Pat. No. 6,458,841 (Topical and oral delivery of arginine to cause beneficial effects). A combination of vasodilators with prehormones of plant origin increased the effectiveness of these compounds, but did not solve the problems described above.
The compound closest in effect to the compound according to the invention (and only partially in terms of composition) is the compound Progene with the composition: Nugenix testosterone complex, Zn, B6, B12. Nugenix testosterone complex is the commercial name of the mixture of three components. Testofen—source of prehormones and steroids, L-citrulline malate-arginine precursor, which ensures activation of vasodilatory processes in the body, Tribulus terrestris—source of natural saponin steroids. This combination proved to be very effective, but this compound also does not have a prolonged effect and does not ensure stable remission of the mechanisms of testosterone production. However, like any source of steroids, when taken chronically, it causes an entire series of functional disorders in the body.
Thus, the question of how to enhance active testosterone synthesis in the body for a prolonged period, without hormones and steroids, remains to be solved.